BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPRESSION ANASTOMOSIS RING

    MDR report key: 1327634 · Received September 11, 2008

    Report

    Report Number
    3006298502-2008-00002
    Event Type
    Injury
    Date Received
    September 11, 2008
    Date of Event
    June 25, 2008
    Report Date
    September 11, 2008
    Manufacturer
    NITI SURGICAL SOLUTIONS LTD
    Product Code
    LNN
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PATIENT WITH HISTORY OF DIVERTICULITIS WITH ENTEROCOLIC FISTULA. SHE WAS ENROLLED ONTO NITI STUDY (B) (4). SURGERY ON (B) (6) 2008 FOR LAPAROSCOPIC SIGMOID COLECTOMY REPAIR OF FISTULA. SHE TOLERATED THE PROCEDURE WELL AND WAS TRANSFERRED POST OPERATIVELY TO THE SURGICAL FLOOR. THE PATIENT WAS KEPT NOP SINCE SHE WAS COMPLAINING OF NAUSEA. ON POD5, SHE HAD ABDOMINAL DISTENTION, VOMITING AND FEVER OF 39.5 C. A CT OF THE ABDOMEN AND PELVIS WAS ORDERED WHICH SHOED A THICK WALLED LOCULATED FLUID COLLECTION SUSPICIOUS FOR ABSCESS. THE PATIENT WAS KEPT NPO AND WAS PLACED ON TPN AND APPROPRIATE ANTIBIOTICS SHE PROGRESSED WELL AND ON POD 10 A REPEAT CT SCAN WAS DONE. WHICH SHOWED A PERSISTENT BUT MUCH SMALLER ABSCESS FLUID COLLECTION. THE PATIENT REMAINED STABLE AND WAS ADVANCED TO REGULAR DIET. SHE WAS ALSO HAVING BOWEL MOVEMENTS. HER SYMPTOMS OF NAUSEA, VOMITING AND ABDOMINAL DISTENTION RESOLVED. SHE WAS DISCHARGED ON POD 12 TO HOME ON ORAL ANTIBIOTICS AND WITH A PLAN TO REPEAT CT SCAN IN 2 WEEKS ALONG WITH A CLINIC VISIT FOR FOLLOW UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPRESSION ANASTOMOSIS RING CAR 27 LNN NITI SURGICAL SOLUTIONS LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization